LAUSR

Objectives: To review the rollout process for Kaftrio® at this large adult CF Centre following approval by the European Medicines Agency (EMA) in June 2020, EMA marketing authorisation and commissioning by NHS England on 21st August 2020, taking into consideration the limitations imposed on clinical services due to COVID-19. Methods: Recent rollout of Symkevi® meant that this adult CF service had already developed processes for the identification of suitable patients and medication distribution. Due to COVID-19 restrictions, innovative methods for clinical review, patient discussion, testing for liver function and occasionally genotype were developed. Furthermore, contract extensions and new paperwork for Homecare companies had to be produced as medication was delivered to patients’ homes. This established process involving multidisciplinary digital consultations, Bluetooth spirometry and self-administered postal blood tests was therefore replicated. Additionally, to ensure access for as many patients as possible we re-checked some genetic mutation results, especially where diagnosis pre-dated current testing technology. Results: This table shows the rate at which our patients were able to access Kaftrio®. Two thirds of patients had access to Kaftrio® a month after it was commissioned and 265 of the 348 eligible patients were taking Kaftrio® within 2 months. [Table presented] Conclusion: Using our experience from the launch of Symkevi®, we were able to adapt to this much larger rollout to despite the limitations imposed by the pandemic. To ensure that patients would benefit from early access we started putting processes in place before Kaftrio® was licensed by the EMA. As soon as commissioning was announced by NHS England, we were ready to start prescribing. This allowed our patients to access Kaftrio® very quickly with 144 out of 348 eligible patients taking their initial dose just over 2 weeks later and 286 patients on treatment after just over 2 months.